Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)

An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercholesterolemia, Mixed Dyslipidemia
What is being tested?: Niacin (+) laropiprant
How many people: 1,166 participants
Where: No sites listed yet
Study dates: Dec 2010to May 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time

Who may be able to join

Participants who are treated with TREDAPTIVE tablet within current local label for the first time
Participants with primary hypercholesterolemia or mixed dyslipidemia
Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance
Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.

Who cannot join

Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period
Participant who has a contraindication to TREDAPTIVE tablet according to the current local label

About this study

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice

Conditions: Hypercholesterolemia, Mixed Dyslipidemia
Being tested: Niacin (+) laropiprant
Keywords: Usual practice re-examination
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Niacin (+) laropiprantDrug
Also called MK-0524A
Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label

Study groups in NCT01228019
Study group	Role	What they receive
All participants		Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) Receives: Drug: Niacin (+) laropiprant

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Any Adverse Experience
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Measured: From start of treatment through 14 days after the last dose (Up to 26 weeks)
Percentage of Participants With Adverse Drug Reactions
An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Measured: From start of treatment through 14 days after the last dose (Up to 26 weeks)
Change From Baseline in Total Cholesterol at Week 12
Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 12
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 12
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 12
Change From Baseline in Triglycerides at Week 12
Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 12
Change From Baseline in Total Cholesterol at Week 24
Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 24
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 24
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24
Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 24
Change From Baseline in Triglycerides at Week 24
Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Measured: Baseline and Week 24
Investigator's Overall Efficacy Evaluation at Week 12
The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.
Measured: Baseline and Week 12
Investigator's Overall Efficacy Evaluation at Week 24
The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010May 2013

First posted25 Oct 2010 (estimated)
Study startDec 2010
Primary completionMay 2013
Study completionMay 2013

Why it stopped: In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01228019
Sponsor's protocol ID: 0524A-119
Status last verified: Apr 2015
First submitted: 22 Oct 2010
Last updated: 21 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice
ClinicalTrials.gov ID: NCT01228019
Acronym / sponsor ID: 0524A-119
Conditions: Hypercholesterolemia, Mixed Dyslipidemia
Keywords: Usual practice re-examination
Study type: Observational
Recruitment status: TerminatedReason stopped: In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs
Enrolment: 1,166 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 25 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Drug: Niacin (+) laropiprantParticipants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time

Key inclusion criteria (4 listed)

Participants who are treated with TREDAPTIVE tablet within current local label for the first time
Participants with primary hypercholesterolemia or mixed dyslipidemia
Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance
Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.

Key exclusion criteria (2 listed)

Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period
Participant who has a contraindication to TREDAPTIVE tablet according to the current local label

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Niacin (+) laropiprantAlso: MK-0524ANiacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label	Drug	All participants

Primary outcome

Percentage of Participants With Any Adverse Experience
Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Percentage of Participants With Adverse Drug Reactions
Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and Week 12
Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and Week 12
Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline and Week 24
Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time frame: Baseline and Week 24
Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline and Week 24
Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Triglycerides at Week 24
Time frame: Baseline and Week 24
Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Investigator's Overall Efficacy Evaluation at Week 12
Time frame: Baseline and Week 12
The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.
Investigator's Overall Efficacy Evaluation at Week 24
Time frame: Baseline and Week 24
The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.

Results and safety

Results posted to the registry on 25 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	1,166	862

Primary outcome: Percentage of Participants With Any Adverse Experience

Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks). Number. Unit: Percentage of participants

Measure	All Participants n = 862
Value	19.61

Population analysed: Safety population: all enrolled participants who met entry criteria regarding safety data

Primary outcome: Percentage of Participants With Adverse Drug Reactions

Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks). Number. Unit: Percentage of Participants

Measure	All Participants n = 862
Value	15.20

Population analysed: Safety population: all enrolled participants who met entry criteria regarding safety data

Primary outcome: Change From Baseline in Total Cholesterol at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	All Participants n = 301
Value	-12.52 (32.44)

Population analysed: Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.

Primary outcome: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	All Participants n = 274
Value	-6.81 (29.20)

Population analysed: Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.

Adverse events

Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALL PARTICIPANTS	7 of 862 (0.8%)	65 of 862 (7.5%)	Not reported

Limitations and caveats (from the sponsor): Study enrollment stopped early due to termination of all TREDAPTIVE studies. Data obtained for participants enrolled prior to termination was analyzed and reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Any Adverse Experience (time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01228019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.